UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003275 |
|---|---|
| Receipt number | R000003964 |
| Scientific Title | Oncogenic/fibrogenic signaling in chronic hepatitis after anti-viral therapy |
| Date of disclosure of the study information | 2010/03/01 |
| Last modified on | 2010/09/01 14:22:34 |
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Basic information
Public title
Oncogenic/fibrogenic signaling in chronic hepatitis after anti-viral therapy
Acronym
Oncogenic/fibrogenic signaling after anti-viral therapy
Scientific Title
Oncogenic/fibrogenic signaling in chronic hepatitis after anti-viral therapy
Scientific Title:Acronym
Oncogenic/fibrogenic signaling after anti-viral therapy
Region
| Japan | Asia(except Japan) | North America |
| Europe |
Condition
Condition
Chronic hepatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate reversibility of oncogenic/fibrogenic signaling after anti-viral therapy
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Change of Smad3 phosphorylation at 24 weeks after sustained virologic response
Key secondary outcomes
SVR
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Peg-IFN alfa-2a plus ribavirin
Interventions/Control_2
entecavir hydrate
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Naive case
2) Chronic hepatitis B viral infection
3) Chronic hepatitis C viral infection
Key exclusion criteria
1) Patients receiving shosaiko-to
2) Patients suffering from autoimmune hepatitis
3) Patients with a history of severe depression or suicidal attempt
4) Pregnant women
5) Patient suffering from liver cancer
6) Allergic reaction to Peg-IFN alfa-2a, ribavirin, or entecavir hydrate
7) Judged by investigator not to be appropriate for inclusion in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Matsuzaki |
Organization
Kansai Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
10-15 Fumizono-chou, Moriguchi
TEL
06-6992-1001
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Matsuzaki |
Organization
Kansai Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
10-15 Fumizono-chou, Moriguchi
TEL
06-6992-1001
Homepage URL
matsuzak@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University liver study group
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka City University
Department of Hepatology
Name of secondary funder(s)
Kurume University
Department of Gastroenterology
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
関西医科大学附属滝井病院（大阪）
大阪市立大学附属病院（大阪）
久留米大学附属病院（福岡）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2010 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 01 | Day |
Last modified on
| 2010 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003964
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
